Specifications of active pharmaceutical chemicals for quality control part I-II

Abstract:

Project Title : Specifications of Active Pharmaceutical Chemicals for Quality controlInvestigator : Associate Professor Suttatip Chantaraskul Associate Professor Suwanna Laungcholatan Assistant Professor Somkiat Rujirawat. Department of Pharmaceutical Chemistry, Faculty of Pharmaceutical Sciences, Chulalongkorn University.Year : 2001Abstract This research sets specifications of 223 active pharmaceutical chemicals for quality control. The specification of each pharmaceutical chemical is divided into 3 parts. Part I sets characteristic of raw materials in accordance to USP24, BP1998, and/or Certificate of Analysis (COA) of the manufacturer. Part I requires analysis of Physical Appearance, Identification, Solubility, Heavy Metal, Loss on Drying, Related Substances, Impurities and Assay etc. Part II includes the In – House Specifications which are recommended additional requirement for production of dosage forms. Conforming to Part II will increase the quality assurance of the raw materials. The specifications in Part II, generally not found in the pharmacopia, include analysis such as : Residual Solvent, Impurity Profile, Particle Size, Bulk Density, Tapped Density, and Shelf Life, etc. Part III is the remark which summarized from the comments (interviews and questionair) from pharmacists working in pharmaceutical plants. The remarks include recommendation for additional analysis such as : color, odor, Impurities, Polymorphism and Dissolution Test, etc. These specifications if required in registration of raw materials will result in higher degree of quality assurance of the finished products in both public and private sector.